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FDA Approves Subcutaneous Ocrevus for Multiple Sclerosis
FDA Approves Subcutaneous Ocrevus for Multiple Sclerosis
September 13, 2024
Ocrevus Zunovo can be administrated by providers twice a year with a 10-minute subcutaneous injection. Ocrevus Zunovo will be available in a few weeks and be priced at parity with Ocrevus IV.
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FDA Approves Subcutaneous Tecentriq to Treat Multiple Cancers
FDA Approves Subcutaneous Tecentriq to Treat Multiple Cancers
September 13, 2024
Tecentriq Hybreza will be available in a few weeks and be priced at parity with the IV Tecentriq 1200 mg vial.
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FDA Warns of Liver Injury with Veozah for Hot Flashes
FDA Warns of Liver Injury with Veozah for Hot Flashes
September 12, 2024
The FDA has identified a probable case of serious drug induced liver injury that occurred in a woman in the United States who had received Veozah. The agency is requiring additional liver blood testing after starting therapy.
FDA Approves Tremfya for Ulcerative Colitis
FDA Approves Tremfya for Ulcerative Colitis
FDA Approves Tremfya for Ulcerative Colitis
September 12, 2024
Tremfya, a monoclonal antibody that blocks IL-23, is also approved to treat patients with plaque psoriasis and active psoriatic arthritis.
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ARS Pharmaceuticals Submits sNDA for Neffy to Treat Anaphylaxis in Small Children
ARS Pharmaceuticals Submits sNDA for Neffy to Treat Anaphylaxis in Small Children
September 11, 2024
If approved, neffy would be the first new delivery method in more than 35 years for small children.
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Study Finds Cap on Out-of-Pocket Costs Saves Cancer Patients $7,000
Study Finds Cap on Out-of-Pocket Costs Saves Cancer Patients $7,000
September 10, 2024
The Inflation Reduction Act’s limit on Medicare Part D spending can lead to savings for patients prescribed oral chemotherapy drugs.
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KFF: Large Numbers of People Clinically Eligible for GLP-1 Drugs
KFF: Large Numbers of People Clinically Eligible for GLP-1 Drugs
September 9, 2024
This analysis finds that 57.4 million adults under the age of 65 could potentially be eligible for GLP-1 drugs based on currently approved FDA indications, including 36.2 million people with obesity.
Evernorth Will Offer a Private-Label Stelara Biosimilar in 2025
Evernorth Will Offer a Private-Label Stelara Biosimilar in 2025
Evernorth Will Offer a Private-Label Stelara Biosimilar in 2025
September 5, 2024
The private-label biosimilar will be available at an 80% discount off Stelara. Evernorth has not released information about which company will be producing the biosimilar.
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Can Outcomes-Based Agreements Work for Weight Loss Drugs?
Can Outcomes-Based Agreements Work for Weight Loss Drugs?
September 4, 2024
Outcomes-based agreements can take away clinical uncertainties, so payers have a guarantee that they're not spending money on something that’s not going to work.
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Analysis: Consumer Out-of-Pocket Drug Costs Rise Faster than Insurer Costs
Analysis: Consumer Out-of-Pocket Drug Costs Rise Faster than Insurer Costs
September 4, 2024
The growth of out-of-pocket and insurer/negotiated prices paralleled one another until 2016 when negotiated and insurer prices began declining
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FDA New Drug Application Accepted for Sebetralstat to Treat Hereditary Angioedema
FDA New Drug Application Accepted for Sebetralstat to Treat Hereditary Angioedema
September 3, 2024
Sebetralstat would be the first oral, on-demand treatment for hereditary angioedema if approved.
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Capital Rx Launches Program for Self-Funded Employers
Capital Rx Launches Program for Self-Funded Employers
August 30, 2024
The new program provides large employers with access to Capital Rx’s technology platform for claim adjudication, invoicing, and reimbursement.
MedImpact Selects Simlandi and an Unbranded Humira Biosimilar
MedImpact Selects Simlandi and an Unbranded Humira Biosimilar
MedImpact Selects Simlandi and an Unbranded Humira Biosimilar
August 29, 2024
MedImpact is not requiring patients currently taking Humira to switch, and all three products are on a preferred tier.
Cigna Prefers Zymfentra on Medical Benefit for Crohn’s Disease and UC
Cigna Prefers Zymfentra on Medical Benefit for Crohn’s Disease and UC
Cigna Prefers Zymfentra on Medical Benefit for Crohn’s Disease and UC
August 29, 2024
Zymfentra is a subcutaneous infliximab product used to treat ulcerative colitis and Crohn’s disease. It has a price of $6,181.08 for two shots over four weeks.
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FDA Assigns Review Date for Mirdametinib in Genetic Neuro-Oncology Condition
FDA Assigns Review Date for Mirdametinib in Genetic Neuro-Oncology Condition
August 28, 2024
The FDA has given mirdametinib a Prescription Drug User Fee Act (PDUFA) action date of Feb. 28, 2025, to treat patients with neurofibromatosis type 1 with tumors that grow along the peripheral nerve.
Pfizer Launches Consumer Access Program for Vaccines and Some Medications
Pfizer Launches Consumer Access Program for Vaccines and Some Medications
Pfizer Launches Consumer Access Program for Vaccines and Some Medications
August 27, 2024
Through the PfizerForAll platform, patients can connect with a healthcare professional, find and book vaccines, order tests, and find medication savings information.
Lilly Introduces Zepbound Single-Dose Vial for Cash-Paying Patients
Lilly Introduces Zepbound Single-Dose Vial for Cash-Paying Patients
Lilly Introduces Zepbound Single-Dose Vial for Cash-Paying Patients
August 27, 2024
The monthly price of the 2.5 mg Zepbound single-dose vial is $399 and the 5 mg dose is $549, which Lilly officials said is in line with the savings program for without insurance.
Express Scripts to Remove Humira from Commercial Formularies
Express Scripts to Remove Humira from Commercial Formularies
Express Scripts to Remove Humira from Commercial Formularies
August 26, 2024
Beginning in 2025, Express Scripts will favor biosimilars of Humira, including its own private-label version.
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FDA Grants Approvals for Two Updated COVID-19 Vaccines
FDA Grants Approvals for Two Updated COVID-19 Vaccines
August 22, 2024
The updated vaccines include the KP.2 strain of the Omicron variant, which is believed to be contributing to the increases in COVID-19 infections this summer.
Study Finds Drug Coverage Changes in Medicare Part D Plans
Study Finds Drug Coverage Changes in Medicare Part D Plans
Study Finds Drug Coverage Changes in Medicare Part D Plans
August 22, 2024
Avalere’s Kylie Stengel talks about the regional shifts in formularies and utilization management in Medicare Part D prescription drug plans.
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FDA to Hold Advisory Committee Meeting for Sotagliflozin in Type 1 Diabetes and CKD
FDA to Hold Advisory Committee Meeting for Sotagliflozin in Type 1 Diabetes and CKD
August 21, 2024
The FDA has assigned a Prescription Drug User Fee Act of Dec. 20, 2024, for Zynquista (sotagliflozin) to control glycemic levels in adults with type 1 diabetes and chronic kidney disease.
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FDA Issues Complete Response Letter for Linvoseltamab for Multiple Myeloma
FDA Issues Complete Response Letter for Linvoseltamab for Multiple Myeloma
August 21, 2024
The FDA identified at a third party fill and finish manufacturer. The issues have been resolved, and reinspection is expected in the next few months.
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Chronic Graft-Versus-Host Disease Medication, Niktimvo, Gains FDA Approval
Chronic Graft-Versus-Host Disease Medication, Niktimvo, Gains FDA Approval
August 15, 2024
This therapy is a first-in-class treatment for chronic graft-versus-host disease, which develops in roughly 42% of those who receive a stem cell of bone marrow transplant.
FDA Grants Accelerated Approval for Rare Liver Disease Drug
FDA Grants Accelerated Approval for Rare Liver Disease Drug
FDA Grants Accelerated Approval for Rare Liver Disease Drug
August 15, 2024
Livdelz is an oral therapy to treat patients with primary biliary cholangitis, a progressive autoimmune disease. It is expected to be available in pharmacies next week.
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Prurigo Nodularis Medicine Nemluvio Approved by FDA
Prurigo Nodularis Medicine Nemluvio Approved by FDA
August 13, 2024
This first-in-class treatment targets multiple disease mechanisms such as itch and inflammation associated with this condition.
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CMS Assigns Reimbursement Code for Investigative Cell Therapy
CMS Assigns Reimbursement Code for Investigative Cell Therapy
August 13, 2024
Prademagene zamikeracel is a cell therapy in development to treat patients with recessive dystrophic epidermolysis bullosa (RDEB), a rare connective tissue disorder.
Top 3 PBMs Provide Coverage for Zymfentra
Top 3 PBMs Provide Coverage for Zymfentra
Top 3 PBMs Provide Coverage for Zymfentra
August 13, 2024
Zymfentra launched in March 2024 as the first subcutaneous formulation of infliximab for patients with ulcerative colitis and Crohn’s disease. It has a list price of $6,181.08 for two shots over four weeks.
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Insurance Companies Starting to Cover Anktiva, a Bladder Cancer Immunotherapy
Insurance Companies Starting to Cover Anktiva, a Bladder Cancer Immunotherapy
August 12, 2024
No information, however, is available about which insurance plans are providing coverage of Anktiva or what the utilization management requirements are.
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Biosimilar Enzeevu Approved by FDA to Treat Neovascular Age-Related Macular Degeneration
Biosimilar Enzeevu Approved by FDA to Treat Neovascular Age-Related Macular Degeneration
August 12, 2024
Enzeevu is biosimilar to Eylea (aflibercept), which was FDA-approved in 2019.
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FDA Issues Complete Response Letter for MDMA-Assisted Therapy for PTSD
FDA Issues Complete Response Letter for MDMA-Assisted Therapy for PTSD
August 12, 2024
In June, an FDA advisory committee voted against approval of midomafetamine capsules (MDMA) for adults living with posttraumatic stress disorder (PTSD).
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